Is FDA OK with General or Shared Passwords?

Q: I’m reviewing our policy on shared passwords and accounts. We’ve issued a limited number of general passwords to supervisors or operators on the production floor so they can retrieve production documents electronically. Under 21 CFR Part 11.300(a), is it…

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Are You Required to Validate Social Media Tools?

Q: I took your course on FDA Auditing of Computerized Systems and Part 11/Annex 11 last year and often refer back to the material when solving compliance questions. But here’s a new one: many companies are now using Facebook, Twitter,…

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Archiving Training Records

Q: Can you tell me how long I should keep training records and when to archive them? We manufacture active pharmaceutical ingredients (APIs) with an expiration date of five years. A: The rule of thumb is to keep training records…

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